Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027327500

FEI Number

3027327500

Entity Name

Jiangsu Yoosun Intelligent Technology Company Limited

City/State/Country

Changshu Jiangsu, CN

Establishment Address

No. 278 Hua Lian Road, Meili Town, Changshu Jiangsu 215511, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Jiangsu Yoosun Intelligent Technology Company Limited (Owner Number: 10087651)

Owner / Operator Contact Address

No. 278 Hua Lian Road, Meili Town, Changshu, CN-JS 215511, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

weighted blanket; weighted heating pad Far-infrared lamp heating pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2023-03-23
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-03-05

Official Correspondent

Yazhen Chen

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Jiangsu Yoosun Intelligent Technology Company Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027327500. Last updated year: 2026. Please use registration number 3027327500 when referencing this establishment in official correspondence.